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The African Medicines Agency (AMA) is a proposed specialised agency of the African Union (AU) intended to facilitate the harmonisation of medical regulation throughout the African Union. Following a similar model to that of the European Medicines Agency , it is intended to have a wide scope covering medicines , traditional medicine , and ...
Section 28(1) of the Medicines and Related Substances Control Act gave inspectors of medicines the authority to enter into and inspect any premises, place, vehicle, vessel or aircraft where such inspectors reasonably believed there were medicines or other substances regulated by the Act, and to seize any medicine or books, records or documents found in or upon such premises, place, vehicle ...
"Prior acts" (or "nose") coverage transfers the retro-active date for an old policy to a new insurance carrier—eliminating the need to purchase tail coverage from the last carrier. Nose coverage is usually less expensive than purchasing tail coverage from the old carrier. Tail coverage costs 2–3 times the expiring premium.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
When Michael Adams was researching health insurance options in 2023, he had one very specific requirement: coverage for prosthetic limbs. The roughly $50,000 leg with the electronically controlled ...
When Michael Adams was researching health insurance options in 2023, he had one very specific requirement: coverage for prosthetic limbs. Adams, 51, lost his right leg to cancer 40 years ago, and ...
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...